Developing Biomarkers for Fibromyalgia (Biomarkers)

This study has been completed.

Sponsor:

University of Michigan

ClinicalTrials.gov Identifier:

NCT00932061

First Posted: July 2, 2009

Last Update Posted: July 19, 2013

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The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.

Fibromyalgia subjects will be randomized to receive 9 acupuncture treatments over the course of four weeks.

Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.

Sham Comparator: Sham Treatment

Sham acupuncture is used.

Other: Sham Treatment

Fibromyalgia subjects will be randomized to receive 9 sham treatments over the course of four weeks.

Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Inclusion Criteria for Fibromyalgia Volunteers:

Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year

Chronic pain more than 50% of days

Willing to limit introduction of any new medications or treatments for fibromyalgia during the study

Able to attend study visits up to three times weekly

Right-handed

Be capable of giving written informed consent

Inclusion Criteria for Healthy Volunteers:

Willing to refrain from alcohol intake for 48 hours prior to brain scans

Be right handed

Be capable of giving written informed consent

PET Inclusion Criteria:

Willing to refrain from alcohol intake 48 hours prior to brain scans

Capable of giving written consent

Exclusion Criteria:

Exclusion Criteria for Fibromyalgia Volunteers:

Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)

Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture